Safety and Preliminary Efficacy of FAB117-HC in Patients With Acute Traumatic Spinal Cord Injury
About this trial
This trial is recruiting individuals with acute thoracic (chest area) spinal cord injuries to test the safety and effect of a stem cell application. Stem cells have been reported in animal studies to limit secondary cell damage and promote nerve regeneration. This study investigates the use of adipose (fat)-derived (mesenchymal) stems cells. Decompression and stabilization surgery (DSS) of the spinal column is routinely performed after SCI, and it is at this time the stem cells (derived from fat cells) can also be injected into the injured spinal cord. The study has two focuses: cell injection versus a control group (no cells), and a lower dose of cells versus a higher dose. If selected participants will undergo routine DSS within 5 days after SCI. Participants will then either receive the stem cell injection or no stem cell injection; neither participant nor investigator will know the treatment administered. In the follow-up period, participants will undergo neurological testing for any changes in sensory and motor function.
Included participants
Traumatic
Non-traumatic
What’s involved
Type
Details
A single-dose injection of the stem cell treatment into the injury site. Follow-up neurological testing for 1 year.
Potential benefits
Main benefits
General health
Additional benefits
Arm/hand function
Standing/walking/mobility
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Unknown
- Trial start date
- 1 Dec 2016
- Organisation
- Ferrer Internacional S.A.
- Trial recruitment status
- Unknown
- Trial start date
- 1 Dec 2016
- Organisation
- Ferrer Internacional S.A.
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more